The present invention relates to a delivery catheter assembly. In particular, the present invention is directed to a delivery catheter assembly for use in surgical procedures to whereby a first component is secured to a second component using a fastener delivered to the surgical site by the delivery catheter assembly.
An aneurysm is a ballooning of the wall of an artery resulting from the weakening of the artery due to disease or other conditions. Left untreated, the aneurysm will frequently rupture, resulting in loss of blood through the rupture and death.
Aortic aneurysms are the most common form of arterial aneurysm and are life threatening. The aorta is the main artery which supplies blood to the circulatory system. The aorta arises from the left ventricle of the heart, passes upward and bends over behind the heart, and passes down through the thorax and abdomen. Among other arterial vessels branching off the aorta along its path, the abdominal aorta supplies two side vessels to the kidneys, the renal arteries. Below the level of the renal arteries, the abdominal aorta continues to about the level of the fourth lumbar vertebrae (or the navel), where it divides into the iliac arteries. The iliac arteries, in turn, supply blood to the lower extremities and perineal region.
It is common for an aortic aneurysm to occur in that portion of the abdominal aorta between the renal arteries and the iliac arteries. This portion of the abdominal aorta is particularly susceptible to weakening, resulting in an aortic aneurysm. Such an aneurysm is often located near the iliac arteries. An aortic aneurysm larger than about 5 cm in diameter in this section of the aorta is ominous. Left untreated, the aneurysm may rupture, resulting in rapid, and usually fatal, hemorrhaging. Typically, a surgical procedure is not performed on aneurysms smaller than 5 cm because no statistical benefit exists in performing such procedures.
Aneurysms in the abdominal aorta are associated with a particularly high mortality rate; accordingly, current medical standards call for urgent operative repair. Abdominal surgery, however, results in substantial stress to the body. Although the mortality rate for an aortic aneurysm is extremely high, there is also considerable mortality and morbidity associated with open surgical intervention to repair an aortic aneurysm. This intervention involves penetrating the abdominal wall to the location of the aneurysm to reinforce or replace the diseased section of the aortic aneurysm. A prosthetic device, typically a synthetic tube graft, is used for this purpose. The graft serves to exclude the aneurysm from the circulatory system, thus relieving pressure and stress on the weakened section of the aorta at the aneurysm.
Repair of an aortic aneurysm by surgical means is a major operative procedure. Substantial morbidity accompanies the procedure, resulting in a protracted recovery period. Further, the procedure entails a substantial risk of mortality. While surgical intervention may be indicated and the surgery carries attendant risk, certain patients may not be able to tolerate the stress of intra-abdominal surgery. It is, therefore, desirable to reduce the mortality and morbidity associated with intra-abdominal surgical intervention.
In recent years, methods have been developed to attempt to treat an aortic aneurysm without the attendant risks of intra-abdominal surgical intervention. Among them are inventions disclosed and claimed in Kornberg, U.S. Pat. No. 4,562,596 for Aortic Graft, Device and Method for Performing an Intraluminal Abdominal Aortic Aneurysm Repair; Lazarus, U.S. Pat. No. 4,787,899 for Intraluminal Graft Device, System and Method; and Taheri, U.S. Pat. No. 5,042,707 for Intravascular Stapler, and Method of Operating Same.
Although in recent years certain techniques have been developed that may reduce the stress, morbidity, and risk of mortality associated with surgical intervention to repair aortic aneurysms, none of the systems that have been developed effectively treat the aneurysm and exclude the affected section of aorta from the pressures and stresses associated with circulation. None of the devices disclosed in the references provide a reliable and quick means to reinforce an aneurysmal artery. In addition, all of the prior references require a sufficiently large section of healthy aorta surrounding the aneurysm to ensure attachment of the graft. The neck of the aorta at the cephalad end (i.e., above the aneurysm) is usually sufficient to maintain a graft""s attachment means. However, when an aneurysm is located near the iliac arteries, there may be an ill-defined neck or no neck below the aneurysm. Such an ill-defined neck would have an insufficient amount of healthy aortic tissue to which to successfully mount a graft. Furthermore, much of the abdominal aorta wall may be calcified which may make it extremely difficult to attach the graft to the wall. Furthermore, the prior art does not disclose surgical devices that can be used during a surgical procedure that address these concerns. Others have developed devices that are not easily manipulated or oriented during intraluminal surgical procedures.
It is an object of the present invention to provide an assembly for use in connection with securing a surgical component to a vessel during a surgical procedure.
It is another object of the present invention to provide a delivery catheter assembly for delivering and inserting a fastener assembly at a desired location during a surgical procedure.
It is another object of the present invention to provide a delivery catheter assembly that may be easily advanced within a vessel during a surgical procedure.
It is another object of the present invention to provide a procedure for securing a surgical component to a vessel.
It is another object of the present invention to provide an assembly for firmly securing a graft assembly to an aortic wall.
It is another object of the present invention to provide an assembly for use in the repair of an aortic aneurysm.
It is another object of the present invention to provide an apparatus for securing a surgical component to a vessel during a minimally invasive surgical procedure.
It is another object of the present invention to provide a delivery catheter having a tip that is capable of unidirectional deflection.
It is another object of the present invention to provide a delivery catheter having a tip that is capable of multi-directional deflection.
It is another object of the present invention to provide a torqueable delivery catheter.
It is another object of the present invention to provide a delivery catheter having at least one wire assembly embedded within the delivery catheter to permit deflection of the tip of the delivery catheter.
The present invention is directed to a delivery catheter assembly for advancing a surgical device to a desired location within a vessel during a surgical procedure. The delivery catheter assembly includes an inner sheath assembly through which the surgical device is advanced to the desired location within the vessel. The delivery catheter assembly further includes an outer sheath assembly surrounding the inner sheath assembly. In accordance with the present invention, at least one of the inner sheath assembly and the outer sheath assembly has an angular configuration at a predetermined time during the surgical procedure. The present invention further includes an adjusting assembly for creating the angular configuration of at least one of the inner sheath assembly and the outer sheath assembly. The adjusting assembly may include at least one pull wire positioned within one of the inner sheath and the outer sheath. Furthermore, the inner sheath assembly is movable with respect to the outer sheath assembly. The inner sheath assembly is capable of moving between an extended position and a retracted position at the predetermined time during the surgical procedure.
The present invention is also directed to an assembly for use in securing a surgical component to a vessel during a surgical procedure. The assembly includes a catheter delivery assembly and an insertion assembly. The delivery catheter assembly may include an inner sheath assembly through which the surgical device is advanced to a desired location within the vessel, and an outer sheath assembly surrounding the inner sheath assembly. The insertion assembly may include an assembly for creating an aperture within the surgical component and the vessel such that a fastener assembly may be inserted there through. The assembly may further include an advancing assembly for advancing the delivery catheter assembly to the desired location within the vessel during the surgical procedure. The advancing assembly may include a delivery sheath, wherein the delivery catheter assembly may be slidably received with the delivery sheath.
The assembly of the present invention may also include an inner sheath assembly and an insertion assembly adapted to contain at least one fastener assembly, or adapted to contain at least two fastener assemblies, wherein the at least two fastener assemblies are aligned co-linearly in a distal-proximate orientation. The inner sheath assembly and the insertion assembly may further comprise dispensing means to controllably deliver an individual fastener assembly to secure the surgical component to the vessel. The fastener assembly may be located outside of the insertion assembly, or located within the insertion assembly. The fastener assemblies may further comprise a diluting tip at their distal end. The fastening assemblies may be attached to one another by a detachable means, wherein the detachable means may comprise at least one of mechanical force, electrical pulse, heat, dissolving a temporary connecting memberane, and shearing a temporary connecting membrane.
The present invention is also directed to a method of securing a surgical component to a vessel, comprising the steps of advancing a delivery sheath containing a catheter assembly through a vessel to a procedure specific area within the vessel, extending the catheter assembly such that an outer sheath of the catheter assembly extends from the delivery sheath, wherein an end portion of the outer sheath assumes an angular configuration, advancing an inner sheath from within the outer sheath such that the outer sheath contacts a surgical component at a location opposite to a point of contact of the inner sheath, further advancing the inner sheath such that the inner sheath applies sufficient pressure on the surgical component to push the surgical component firmly against the vessel, advancing an insertion assembly from within the inner sheath to create an aperture in the surgical component and the vessel through which a fastener assembly extends, advancing the insertion assembly and the fastener assembly through the aperture, and retracting the insertion assembly and the inner sheath such that the fastener assembly secures the surgical component to the vessel. The method according to the present invention may also comprise the steps of activating a laser fiber assembly, prior to advancing the insertion assembly and the fastener assembly through the aperture, to create the aperture through which the fastener assembly extends, or activating a piezoelectric device, prior to advancing the insertion assembly and the fastener assembly through the aperture, to create the aperture through which the fastener assembly extends.
The method according to the present invention may also include the steps of manipulating the catheter assembly within the vessel to another location, after retracting the insertion assembly and the inner sheath. The insertion assembly and the fastener assembly may advance through an aperture simultaneously, or the advancement of the insertion assembly through the aperture may precede the advancement of the fastener assembly through the aperture.
The present invention is also directed to a method of securing a surgical component to a vessel, the method comprising the steps of inserting a surgical component into a vessel at an entry site, moving the surgical component to a location within the vessel remote from the entry site, holding the surgical component in place within the vessel by a securing means, inserting a delivery catheter into the vessel, wherein the delivery catheter contains a fastening assembly, maneuvering the delivery catheter to a location in close proximity to the surgical component, deploying the fastening assembly to attach the surgical component to the vessel, manipulating the fastener assembly to secure the surgical component to the vessel, and removing the delivery catheter from the vessel. The surgical component, and/or an insertion assembly may be contained within the delivery catheter. The fastening assembly may be inserted into an aperture from the outside of the insertion assembly or from within the insertion assembly.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only, and are not restrictive of the invention, as claimed. The accompanying drawings, which are incorporated herein by reference, and which constitute a part of this specification, illustrate certain embodiments of the invention, and together with the detailed description serve to explain the principles of the present invention.